CHANGES TO FEDERAL POLICY FOR PROTECTION OF HUMAN SUBJECTS (COMMON RULE) Anca Miron, PhD IRB Chair, UW Oshkosh Kelly Schill, BS, CIP IRB Administrator, UW Oshkosh https://www.powerslaw.com/final-rule-revisions-common-rule/ Introductions The goal of today’s presentation is twofold: 1) to provide you with some info about existing federal and institutional IRB rules and processes; 2) to give an update on changes to the common rule that will be coming into effect early next year, more precisely January 19, 2018

Regulatory Changes to the Common Rule Changes Effective July 19, 2018: Changes focus on reducing administrative burden for IRBs and researchers while protecting human subjects Several of the changes reduce or remove requirements for low-risk research Additional flexibility allowed within the current regulatory framework Changes impacting researchers: new and revised exempt categories, continuing review, informed consent, and single IRB for collaborative research Note: Single IRB of Record (sIRB) for federally funded research has later implementation date

REVISED and NEW Exempt Categories Revised: Classroom research cannot adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction New: Use of identifiable information may be exempt if IRB conducts a Limited IRB review to determine that the research includes appropriate provisions for protecting privacy and confidentiality New: Research involving benign behavioral interventions on adults; will likely result in the majority of currently-expedited social-behavioral-educational research being exempt New: Secondary research use of information protected by HIPAA; will allow exempt review of retrospective and prospective chart reviews New Exempt Categories may be viewed on IRB Forms page.

Exempt Studies Exempt studies will still be reviewed by IRB members and trained IRB staff to make the IRB exempt determination To note, some activities previously reviewed under expedited categories have been moved to exempt status; e.g., EXEMPT CATEGORY 3, which includes research involving benign behavioral intervention in conjunction with the collection of data from an adult (not minor) through verbal or written responses or audio-recoding; + may include deception if prospectively authorized by the participant

Continuing Review Changes No continuing review required for: exempt or expedited research (unless requested & justified by IRB during limited IRB/expedited review) OR full board research limited to long-term clinical care follow-up only or data analysis only (including identifiable data) Researchers will receive an annual email notification of their ongoing responsibilities to the IRB but no renewal action will be required Any changes to the study will require an IRB Modification Request Form and approval from IRB before implementation. Researchers are still responsible for submitting an IRB Closure Form at the conclusion of their study.

Continuing Review Changes (Continued) Existing protocols approved prior to July 19, 2018, will be grandfathered into the old rules until the time of annual continuing review. At the time of continuing review, the IRB will transition the protocol to the new requirements, unless applying the 2018 Requirements will not provide benefit to investigators or subjects.

Informed Consent Impacts New: Key information at beginning of consent Consent must begin with a concise and focused presentation of key information (e.g. statement that the project is research and that participation is voluntary, a summary of the purpose, duration, procedures, risks, discomforts, benefits, appropriate alternatives, costs and payment). Should be written at an appropriate comprehension level to assist the participant in making a decision on why one may or may not choose to participate in the research

Informed Consent Impacts (Continued) One new required element of consent: Notice about possible future research use of information or biospecimens stripped of identifiers: notifying prospective subject that subjects’ information or biospecimens could be used for future research without additional consent; or will not be used for future research Three new additional elements of consent (when applicable): Potential for commercial profit and sharing of profits with subjects Whether clinically relevant research results will be disclosed to subjects and, if so, under what conditions For research involving biospecimens, whether the research will involve whole genome or exome sequencing

Informed Consent Impacts (Continued) Secondary research use of identifiable private information for which consent is not needed ( See Exempt Category 4) Consent is not needed for data screening/prescreening Must provide participants an opportunity to obtain a copy of the consent form, even for online studies Post online the consent form for clinical trials supported by federal funding The key information section and new elements of informed consent will be included in the new Informed Consent Templates on the IRB forms/templates page: https://grants.uwosh.edu/sample-page/research- compliance/institutional-review-board-irb/irb-forms/

Single IRB Review Requirement for Single IRB Review: all U.S. institutions engaged in federally funded collaborative research for the portion of the research conducted in the U.S. Implementation Date: January 20, 2020, however NIH funded research implemented a single IRB effective date of January 25, 2018 Two exceptions: When more than a single IRB review is required by law Whenever any federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context

Revised Common Rule: Expedited Review No changes to expedited categories of research Continuing review no longer required unless requested and justified/documented by IRB New consent templates available to assist with meeting new requirements Research approved by expedited review-That would be more accurate (however that isn't a change since there is not a continuing review requirement for exempt research now).  The limited IRB research is actually regulated even though it is an exempt category.  Confusing-- I know! IRB can override this default and require continuing review, but this must be documented.

Revised Common Rule: Full Board Review No changes to determination criteria for full-board review: 1) Use of vulnerable populations: Subpart B: Pregnant women (when applicable), neonates, and fetuses Subpart C: Prisoners Subpart D: Children Other potentially vulnerable populations: Diminished Consent Capacity, Cognitively Impaired, Economically/Educationally Disadvantaged, Institutionalized 2) Research involving higher level of risk 3) Use of deception (if the intervention is not benign and/or participants are not informed of deception)

Human Subjects Research Training (CITI Program) Current CITI training is valid until it expires (3 years from date completed) When CITI refresher training is due, the revised human subjects course will be assigned to researchers New researchers will automatically be assigned the revised CITI human subjects research module

Regulatory Update on Revised Common Rule Final Rule on the Revisions to the Federal Policy for the Protection of Human Subjects implementation date was originally January 19, 2018 An Interim Final Rule was published on January 17, 2018, which delayed the revisions 6 months Two additional final rules have been submitted to delay the implementation date and remain under review at OMB There is a chance that further delay may occur, but the current implementation date is July 19, 2018

Website for Common Rule Updates and Summary The Sponsored Programs Office has an IRB webpage focused on the Common Rule Revisions which contains additional resources https://uwosh.edu/sponsoredprograms/common-rule/

Questions?